The Food and Drug Administration (FDA) has imposed restrictions on the prescription of drugs containing montelukast for people with allergic rhinitis, ruling that such medications should only be prescribed after other drugs have been used and failed to be effective.
Drugs containing montelukast could affect a person’s mental health while they are taking the medication or after treatment has stopped, with side effects including changes in behavior, unusual movements or suicidal thoughts, the FDA said in a statement yesterday.
Hung Kuo-teng (洪國登), head of the FDA’s Medicinal Products Division, told reporters that there are 31 drug permit licenses that have been issued in Taiwan for medications containing montelukast, which is used to treat asthma and allergic rhinitis, a type of nasal inflammation that occurs when the immune system overreacts to allergens in the air.
Citing National Health Insurance data, Hung said that each year, about 900,000 prescriptions of medication containing montelukast are given out.
Last year, the US Food and Drug Administration issued a warning against drugs containing montelukast, saying that their clinical effectiveness was not shown to be greater than the potential risk they posed to people’s mental health.
It then determined that they should not be used until other medications for allergic rhinitis have been used and found to be ineffective, Hung said.
In light of the warning, Taiwan’s FDA re-evaluated the effectiveness and risk of such medications, and its drug safety assessment panel determined that while drugs containing montelukast are effective in treating allergic rhinitis, they might also cause people to develop mental health problems, Hung said.
As a result, the agency has decided to list those medications as “rear-line” drugs, meaning that they can only be prescribed when other medications for nasal inflammation caused by allergies have failed to be effective, Hung said, adding that there are other drugs for treating asthma.
The ruling went into effect immediately.
The companies that hold permit licenses for drugs containing montelukast have been told to change the content of their package inserts before July 31 so that they state that the drugs can only be used when other medications for allergic rhinitis have failed to be effective, Hung said.
Companies that fail to make the change before the deadline would have their drug permit license revoked, Hung said.
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